Status:
COMPLETED
Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).
Lead Sponsor:
Celgene
Conditions:
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486, known as oral azacitidine, in patients with AML or MDS after allogeneic hematopoetic stem cell transplant (H...
Detailed Description
This is an open-label, multicenter study of oral azacitidine in MDS or AML patients who have undergone allogeneic HSCT. The study consists of three phases: Screening, Treatment and Follow-up. During t...
Eligibility Criteria
Inclusion
- Histologically confirmed Myelodysplastic Syndromes or Acute Myeloid Leukemia undergoing allogeneic hematopoietic stem cell transplantation with either peripheral blood or bone marrow as the source of hematopoietic stem cells
- At the time of allogeneic HSCT:
- No prior allogeneic HSCT; and
- No more than 1 antigen mismatch at Human Leukocyte Antigen (HLA)-A, -B, -C, -DRB1 or -DQB1 locus for either related or unrelated donor; and
- Bone marrow blast \< 20% if MDS or ≤ 10% if AML; and
- Peripheral blood blast ≤ 5%
- Be able to start study drug between 42 to 84 days following allogeneic HSCT
- Post transplant bone marrow blast count ≤ 5% confirmed within 21 days prior to starting study therapy
- Adequate engraftment within 14 days prior to starting study therapy:
- Absolute Neutrophil count (ANC) ≥ 1.0 x 10\^9/L without daily use of myeloid growth factor; and
- Platelet count 75 x 10\^9/L without platelet transfusion within one week.
- Adequate organ function:
- Serum aspartate transaminase (AST) and alanine transaminase (ALT) \< 3 x upper limit of normal (ULN)
- Serum bilirubin \< 2 x ULN
- Serum creatinine \< 2 x ULN
- Adequate coagulation (Prothrombin time \[PT\] ≤ 15 seconds, Partial thromboplastin time (PTT) ≤ 40 seconds, and/or International normalized ratio \[INR\] ≤ 1.5)
- Have a negative serum pregnancy test (sensitivity of at least 25 mIU/mL at screening).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Must agree to follow protocol-specified pregnancy precautions
Exclusion
- Use of any of the following after transplantation and prior to starting oral azacitidine:
- Chemotherapeutic agents for chemotherapy
- Investigational agents/therapies
- Azacitidine, decitabine or other demethylating agents
- Lenalidomide, thalidomide and pomalidomide
- Active Graft-versus-host disease (GVHD) grade II or higher
- Any evidence of gastrointestinal (GI) GVHD
- Concurrent use of corticosteroids equivalent of prednisone at a dose \> 0.5 mg/kg
- Known active viral infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
- Active uncontrolled systemic fungal, bacterial or viral infection
- Presence of malignancies, other than MDS or AML, within the previous 12 months
- Significant active cardiac disease within the previous 6 months
Key Trial Info
Start Date :
October 25 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2017
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01835587
Start Date
October 25 2013
End Date
May 26 2017
Last Update
November 20 2018
Active Locations (5)
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1
Memorial Sloan-Kettering Cancer Center.
New York, New York, United States, 10065
2
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
3
MD Anderson Cancer Center The University of Texas
Houston, Texas, United States, 77030
4
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-4417